FDA has concerns over bioequivalence of two Concerta generics
- After analyzing bioequivalence data, the FDA has issued an alert that two generic versions of Concerta (methylphenidate hydrochloride) made by Mallinckrodt and Kudco, may not be therapeutically equivalent to the brand-name product.
- The FDA has not identified any serious safety concerns with these products, despite concerns about lack of therapeutic equivalence.
- The FDA is urging patients to consult with their doctors about lack of therapeutic efficacy if they are having problems.
According to the World Health Organization (WHO), a generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.
The FDA complies with that definition and oversees the generics market to ensure therapeutic equivalence. Since 1984, when the Hatch-Waxman Act was enacted, bioequivalence has been used as the basis for approval of generic drugs. For the most part, generics have proven to be equally effective, safe and tolerable when compared to original innovator products, thanks largely to intensive FDA oversight. This product alert is a positive byproduct of that oversight.